NCT06575374

Single Arm Pilot Trial of Letermovir for CMV Prophy in CAR T Cell

Open Label Single Arm Pilot Trial of Letermovir for Cytomegalovirus Prophylaxis After Axicabtagene Ciloleucel Therapy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical research study is to learn if a drug called Letermovir can help to prevent CMV reactivation.

Detailed description

Primary Objective: Estimate the probabilities at days d = +28 and +98 following CAR T cell infusion, among patients alive at the day of evaluation, of CMV reactivation in CMV seropositive patients receiving letermovir for CMV prophylaxis after standard of care (SOC) axicabtagene ciloleucel (AXI-CEL) therapy, using the cutoff CMV DNA qPCR \> c for c = 400 and 1000 IU/mL to define CMV reactivation, for a total of four (d, c) combinations. Secondary Objectives: Estimate overall survival probabilities at days+28, +98, and +364 following CAR T cell infusion of CMV seropositive patients receiving letermovir for CMV prophylaxis after SOC AXI-CEL therapy. Describe the tolerability of letermovir during the period of CMV prophylaxis after SOC AXI-CEL therapy in CMV seropositive patients at high risk for CMV reactivation.

Conditions

• Cell Therapy

Interventions

Type	Name	Description
DRUG	Letermovir	Given by mouth or intravenously

Timeline

• Start date: 2024-12-12
• Primary completion: 2026-08-01
• Completion: 2027-08-01
• First posted: 2024-08-28
• Last updated: 2026-01-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study